BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RUERESULT

    MDR report key: 3202082 · Received June 27, 2013

    Report

    Report Number
    1033800-2013-00116
    Event Type
    Malfunction
    Date Received
    June 27, 2013
    Date of Event
    May 28, 2013
    Report Date
    June 27, 2013
    Manufacturer
    NIPRO DIAGNOSTICS, INC
    Product Code
    JJX
    PMA / PMN Number
    K080641
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT NOT YET RETURNED FOR EVAL. (B)(4).

    Description of Event or Problem · 1

    CONSUMER COMPLAINT OF LOW BLOOD GLUCOSE RESULTS. PER THE CALLER, RESULT YESTERDAY WAS 58 MG/DL AND IT SHOULD HAVE BEEN 110 MG/DL. NO ADVERSE EVENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    293337 RUERESULT BLOOD GLUCOSE SYSTEM JJX NIPRO DIAGNOSTICS, INC TRUERESULT PP1131

    Patients

    Seq Age Sex Outcome Treatment
    1